Exhibit 99.3
PDL BioPharma, Inc.
Q3 2014
November 10, 2014
Following are some of the key points regarding PDL’s third quarter 2014 financial and business results.
Net Income
Net income in the third quarter of 2014 was $102.2 million, or $0.61 per diluted share, as compared with net income in the third quarter of 2013 of $56.2 million, or $0.36 per diluted share. Net income for the first nine months of 2014 was $267.2 million, or $1.62 per diluted share, as compared with net income in the first nine months of 2013 of $203.4 million, or $1.31 per diluted share.
Royalty Acquisition
On November 6, 2014, PDL acquired a portion of all royalty payments of the University of Michigan’s (“U-M”) worldwide royalty interest in Cerdelga™ (eliglustat) for $65.6 million. Under the terms of the royalty agreement, PDL will receive 75 percent of all royalty payments due under U-M’s license agreement with Genzyme until expiration of the licensed patents, excluding any patent term extension. Cerdelga, an oral therapy for adult patients with Gaucher disease type 1, was developed by Genzyme, a Sanofi company. Cerdelga was approved by the U.S. Food and Drug Administration (FDA) on August 19, 2014. In addition to the recent FDA approval, marketing applications for Cerdelga are under review by the European Medicines Agency and other regulatory authorities.
2014 Dividends
On January 29, 2014, PDL’s Board of Directors declared regular quarterly dividends of $0.15 per share of common stock, payable on March 12, June 12, September 12 and December 12 of 2014 to all stockholders who own shares of PDL on March 5, June 5, September 5 and December 5 of 2014, the record dates for each of the dividend payments, respectively. On September 12, 2014, PDL paid the third quarterly dividend to stockholders of record totaling $24.0 million using earnings generated in the third quarter of 2014.
Updates on Approved Royalty Bearing Products related to Queen et al. patents
Avastin® (bevacizumab):
| |
• | On October 16, 2014, Genentech/Roche reported that YTD worldwide sales were CHF 4.749 billion and increased by 6%. |
| |
◦ | EU: Strong growth driver by further uptake in ovarian and breast cancer. |
| |
◦ | US: Continued increase in metastatic colorectal cancer. |
| |
◦ | Japan: Increased demand in colorectal, breast and ovarian cancers as well as glioblastoma. |
| |
◦ | International: Launches for ovarian cancer and uptake in colorectal cancer. |
| |
• | On August 14, 2014, Genentech announced US approval for the treatment of persistent, recurrent or metastatic cervical cancer in combination with chemotherapy. |
| |
• | On July 21, 2014, Genentech announced that its application for approval for the treatment of recurrent platinum-resistant ovarian cancer in US had been granted priority review with a PDUFA date of November 19, 2014. |
| |
• | On August 6, 2014, Roche reported EU approval for the treatment of ovarian cancer that is resistant to platinum-based chemotherapy. |
Herceptin® (trastuzumab):
| |
• | On October 16, 2014, Genentech/Roche reported that YTD worldwide sales were CHF4.679 billion and increased by 7%. |
| |
◦ | Positive growth in all regions driven by higher volumes/prolonged treatment times. |
| |
◦ | US: Continued growth in first line metastatic HER2+ breast cancer. |
| |
◦ | EU: Strong demand in Germany, Spain and UK. |
| |
◦ | Japan: Increased usage in combination with Perjeta in HER2+ breast cancer, as well in gastric cancer. |
| |
◦ | International: Growth driven by China and Brazil. |
Lucentis® (ranibizumab):
| |
• | On Oct. 16, 2014, Genentech/Roche reported that YTD US sales were CHF1.260 billion and increased by 5%. |
| |
• | On October 28, 2014, Novartis reported that 3Q14 ex-US sales were $614 million and increased by 7%. |
PDL BioPharma, Inc.
Q3 2014
November 10, 2014
| |
• | On August 7, 2014, Genentech filed in US for approval for treatment of diabetic retinopathy. |
| |
◦ | Diabetic retinopathy is the leading cause of new cases of blindness of working-age people. |
| |
• | October 17, 2014, Regeneron announced top line results from a three-arm trial comparing its drug Eylea with Avastin and Lucentis in patients with diabetic macular edema which showed a greater change in best corrected visual acuity in patients treated with Eylea compared those treated with either Avastin or Lucentis. |
Xolair® (omalizumab):
| |
• | On October 16, 2014, Genentech/Roche reported that YTD US sales were CHF 701 million and increased by 24%. |
| |
• | On October 28, 2014, Novartis reported that 3Q14 ex-US sales were $207 million and increased by 39%. |
| |
• | In March 2014, both Genentech/Roche and Novartis reported US and EU had approvals, respectively, for treatment of chronic idiopathic urticaria. |
| |
• | On September 26, 2014, FDA updated the label to warn about a slightly increased risk of cardiovascular and cerebrovascular events as well as a potential risk of cancer. |
Tysabri® (natalizumab):
| |
• | On October 22, 2014, Biogen Idec reported that 3Q14 worldwide sales were $501 million. |
Actemra® (tocilizumab):
| |
• | On October 16, 2014, Genentech/Roche reported that YTD worldwide sales were CHF 897 million and increased by 24% year over year. |
| |
◦ | EU: Continued growth driven by strong monotherapy patient shares in all lines with encouraging subcutaneous adoption. |
| |
◦ | US: Growth is driven by strong IV demand and subcutaneous patient share uptake (~80% of new patients). |
| |
◦ | Subcutaneous formulation approved in US and EU in October 2013 and April 2014, respectively. |
| |
• | On September 8, 2014, Roche announced EU approval for treatment of patients with early rheumatoid arthritis. |
Perjeta® (pertuzumab):
| |
• | On October 16, 2014, Genentech/Roche reported YTD worldwide sales were CHF 633 million and increased by 255% year over year. |
| |
◦ | Growth driven by continued strong uptake in first and second line metastatic HER2+ breast cancer and in the neoadjuvant setting in the US. |
| |
• | On September 28, 2014, Genentech/Roche announced that final data from Phase 3 study in patients with previously untreated HER2+ metastatic breast cancer who were treated with Perjeta, Herceptin and docetaxel lived a median of 56.5 months compared to 40.8 months for patients treated with Herceptin and docetaxel. Median overall survival of almost five years is the longest observed to date in patients with metastatic HER2+ breast cancer. |
Kadcyla® (TDM-1 or ado-trastuzumab emtansine):
| |
• | On October 16, 2014, Genentech/Roche reported YTD worldwide sales were CHF 371 million and increased by 148%. |
| |
◦ | Strong uptake in second line metastatic HER2+ breast cancer. |
| |
• | MARIANNE results expected in 4Q14. |
Gazyva™ (Obinutuzumab or GA101):
| |
• | On October 16, 2014, Genentech/Roche announced YTD worldwide sales of CHF 32 million. |
| |
• | Gazyva was approved in the US on November 1, 2013, for previously untreated chronic lymphocytic leukemia (CLL) in combination with chlorambucil. |
| |
• | On July 29, 2014, Roche announced EU approval for first line treatment of CLL with chlorambucil. |
PDL BioPharma, Inc.
Q3 2014
November 10, 2014
Updates on Acquired Royalties from Depomed
| |
• | Current royalty bearing products include: |
| |
◦ | Glumetza (U.S, sold by Santarus / Salix) |
| |
◦ | Glumetza (Canada, sold by Valeant Pharmaceuticals) |
| |
◦ | Glumetza (Korea, sold by LG Life Sciences) |
| |
◦ | Janumet XR (world-wide, Sold by Merck) |
| |
• | Additional products for which we may receive milestones and royalties |
| |
◦ | Combination of Invokana® (canagliflozin) and extended-release metformin (Janssen Pharmaceutica) |
| |
◦ | Two investigational fixed-dose combinations of drugs and extended-release metformin (Boehringer Ingelheim) |
| |
• | Since inception of the transaction (October 2013) to date we have received $93.7 million in cash from this transaction, which includes $82.5 million in cash for the year to date September 30, 2014. |
Forward-looking Statements
This document contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of the Company's royalty assets, restrict or impede the ability of the Company to invest in new income generating assets and limit the Company's ability to pay dividends are disclosed in the risk factors contained in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by subsequent filings. All forward-looking statements are expressly qualified in their entirety by such factors. We do not undertake any duty to update any forward looking statement except as required by law.
PDL BioPharma, Inc.
Q3 2014
November 10, 2014
|
| | | | | | | | | | |
Queen et al. Royalty Revenue by Product ($ in 000's) * |
Avastin | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 38,122 |
| 38,924 |
| 38,864 |
| — |
| 115,910 |
|
2013 | 33,234 |
| 46,720 |
| 32,224 |
| 32,287 |
| 144,464 |
|
2012 | 23,215 |
| 41,670 |
| 25,955 |
| 30,041 |
| 120,882 |
|
2011 | 22,283 |
| 41,967 |
| 23,870 |
| 22,886 |
| 111,006 |
|
2010 | 16,870 |
| 44,765 |
| 29,989 |
| 24,922 |
| 116,547 |
|
2009 | 13,605 |
| 35,161 |
| 21,060 |
| 15,141 |
| 84,966 |
|
2008 | 9,957 |
| 30,480 |
| 19,574 |
| 12,394 |
| 72,405 |
|
2007 | 8,990 |
| 21,842 |
| 17,478 |
| 9,549 |
| 57,859 |
|
2006 | 10,438 |
| 15,572 |
| 15,405 |
| 12,536 |
| 53,952 |
|
| | | | | |
Herceptin | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 36,646 |
| 38,292 |
| 39,407 |
| — |
| 114,345 |
|
2013 | 30,287 |
| 47,353 |
| 30,961 |
| 33,038 |
| 141,640 |
|
2012 | 25,702 |
| 44,628 |
| 30,433 |
| 28,307 |
| 129,070 |
|
2011 | 25,089 |
| 42,209 |
| 31,933 |
| 21,812 |
| 121,042 |
|
2010 | 23,402 |
| 38,555 |
| 27,952 |
| 25,441 |
| 115,350 |
|
2009 | 16,003 |
| 32,331 |
| 26,830 |
| 18,615 |
| 93,779 |
|
2008 | 14,092 |
| 34,383 |
| 28,122 |
| 20,282 |
| 96,880 |
|
2007 | 19,035 |
| 28,188 |
| 22,582 |
| 14,802 |
| 84,608 |
|
2006 | 15,142 |
| 19,716 |
| 21,557 |
| 20,354 |
| 76,769 |
|
| | | | | |
Lucentis | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 17,390 |
| 16,777 |
| 16,883 |
| — |
| 51,050 |
|
2013 | 12,032 |
| 30,066 |
| 13,536 |
| 12,127 |
| 67,760 |
|
2012 | 10,791 |
| 27,938 |
| 12,552 |
| 11,097 |
| 62,377 |
|
2011 | 8,878 |
| 24,313 |
| 12,157 |
| 10,750 |
| 56,099 |
|
2010 | 7,220 |
| 19,091 |
| 10,841 |
| 8,047 |
| 45,198 |
|
2009 | 4,621 |
| 12,863 |
| 8,123 |
| 6,152 |
| 31,759 |
|
2008 | 3,636 |
| 11,060 |
| 7,631 |
| 4,549 |
| 26,876 |
|
2007 | 2,931 |
| 6,543 |
| 6,579 |
| 3,517 |
| 19,570 |
|
2006 | — |
| — |
| 289 |
| 3,335 |
| 3,624 |
|
| | | | | |
Xolair | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 8,886 |
| 9,099 |
| 10,442 |
| — |
| 28,427 |
|
2013 | 5,930 |
| 10,025 |
| 7,334 |
| 7,330 |
| 30,619 |
|
2012 | 5,447 |
| 8,609 |
| 6,504 |
| 6,145 |
| 26,705 |
|
2011 | 4,590 |
| 7,621 |
| 5,916 |
| 5,823 |
| 23,949 |
|
2010 | 3,723 |
| 6,386 |
| 4,980 |
| 4,652 |
| 19,741 |
|
2009 | 2,665 |
| 5,082 |
| 4,085 |
| 3,722 |
| 15,553 |
|
2008 | 1,488 |
| 4,866 |
| 3,569 |
| 2,927 |
| 12,850 |
|
2007 | 1,684 |
| 3,942 |
| 3,332 |
| 2,184 |
| 11,142 |
|
2006 | 2,263 |
| 2,969 |
| 3,041 |
| 2,495 |
| 10,768 |
|
| | | | | |
Perjeta | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 3,375 |
| 4,385 |
| 5,157 |
| — |
| 12,917 |
|
2013 | 340 |
| 1,414 |
| 748 |
| 879 |
| 3,381 |
|
2012 | — |
| — |
| 58 |
| 250 |
| 308 |
|
PDL BioPharma, Inc.
Q3 2014
November 10, 2014
|
| | | | | | | | | | |
Queen et al. Royalty Revenue by Product ($ in 000's) * |
Kadcyla | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 1,934 |
| 2,491 |
| 3,048 |
| — |
| 7,473 |
|
2013 | — |
| 551 |
| 830 |
| 859 |
| 2,240 |
|
| | | | | |
Tysabri | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 12,857 |
| 13,350 |
| 16,048 |
| — |
| 42,255 |
|
2013 | 12,965 |
| 13,616 |
| 11,622 |
| 12,100 |
| 50,304 |
|
2012 | 11,233 |
| 12,202 |
| 11,749 |
| 12,255 |
| 47,439 |
|
2011 | 9,891 |
| 10,796 |
| 11,588 |
| 11,450 |
| 43,725 |
|
2010 | 8,791 |
| 8,788 |
| 8,735 |
| 9,440 |
| 35,754 |
|
2009 | 6,656 |
| 7,050 |
| 7,642 |
| 8,564 |
| 29,912 |
|
2008 | 3,883 |
| 5,042 |
| 5,949 |
| 6,992 |
| 21,866 |
|
2007 | 839 |
| 1,611 |
| 2,084 |
| 2,836 |
| 7,370 |
|
2006 | — |
| — |
| — |
| 237 |
| 237 |
|
| | | | | |
Actemra | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 3,446 |
| 3,932 |
| 4,419 |
| — |
| 11,797 |
|
2013 | 2,631 |
| 2,816 |
| 2,939 |
| 3,744 |
| 12,131 |
|
2012 | 1,705 |
| 2,074 |
| 2,145 |
| 2,462 |
| 8,385 |
|
2011 | 913 |
| 1,136 |
| 1,401 |
| 1,460 |
| 4,910 |
|
2010 | 1,587 |
| 237 |
| 315 |
| 688 |
| 2,827 |
|
2009 | 585 |
| 537 |
| 909 |
| 1,197 |
| 3,228 |
|
2008 | 44 |
| — |
| 146 |
| 369 |
| 559 |
|
2007 | 32 |
| — |
| — |
| 17 |
| 49 |
|
2006 | — |
| — |
| — |
| — |
| — |
|
| | | | | |
Gazyva | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 51 |
| 283 |
| 325 |
| — |
| 659 |
|
| | | | | |
Entyvio | Q1 | Q2 | Q3 | Q4 | Total |
2014 | — |
| — |
| 153 |
| — |
| 153 |
|
| | | | | |
* As reported to PDL by its licensees | | |
Totals may not sum due to rounding | | |
Q1 2014 royalty revenue by product above do not include a $5 million payment received from Genentech in Q1 2014 for a retroactive settlement payment from 2013. |
PDL BioPharma, Inc.
Q3 2014
November 10, 2014
|
| | | | | | | | | | |
Queen et al. Reported Net Sales Revenue by Product ($ in 000's) * |
Avastin | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 1,786,912 |
| 1,838,764 |
| 1,828,900 |
| — |
| 5,454,576 |
|
2013 | 1,653,108 |
| 1,694,678 |
| 1,746,135 |
| 1,819,877 |
| 6,913,798 |
|
2012 | 1,502,757 |
| 1,573,727 |
| 1,551,327 |
| 1,662,977 |
| 6,290,788 |
|
2011 | 1,597,461 |
| 1,582,705 |
| 1,581,095 |
| 1,469,994 |
| 6,231,255 |
|
2010 | 1,506,788 |
| 1,596,892 |
| 1,594,707 |
| 1,646,218 |
| 6,344,605 |
|
2009 | 1,345,487 |
| 1,295,536 |
| 1,439,730 |
| 1,514,053 |
| 5,594,806 |
|
2008 | 980,715 |
| 1,084,930 |
| 1,180,427 |
| 1,239,382 |
| 4,485,454 |
|
2007 | 678,068 |
| 746,587 |
| 797,013 |
| 875,084 |
| 3,096,752 |
|
2006 | 439,318 |
| 516,052 |
| 570,551 |
| 592,897 |
| 2,118,817 |
|
| | | | | |
Herceptin | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 1,731,564 |
| 1,801,990 |
| 1,854,452 |
| — |
| 5,388,006 |
|
2013 | 1,681,574 |
| 1,744,145 |
| 1,681,860 |
| 1,726,551 |
| 6,834,130 |
|
2012 | 1,515,255 |
| 1,625,313 |
| 1,663,695 |
| 1,650,495 |
| 6,454,759 |
|
2011 | 1,391,568 |
| 1,559,975 |
| 1,642,898 |
| 1,432,771 |
| 6,027,211 |
|
2010 | 1,270,846 |
| 1,349,512 |
| 1,300,934 |
| 1,409,310 |
| 5,330,602 |
|
2009 | 1,210,268 |
| 1,133,993 |
| 1,226,435 |
| 1,278,626 |
| 4,849,323 |
|
2008 | 1,105,426 |
| 1,195,215 |
| 1,211,982 |
| 1,186,806 |
| 4,699,428 |
|
2007 | 891,761 |
| 949,556 |
| 979,602 |
| 1,015,033 |
| 3,835,952 |
|
2006 | 529,585 |
| 659,719 |
| 761,099 |
| 803,576 |
| 2,753,979 |
|
| | | | | |
Lucentis | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 818,376 |
| 789,483 |
| 794,503 |
| — |
| 2,402,362 |
|
2013 | 1,203,179 |
| 1,171,423 |
| 1,200,791 |
| 1,212,651 |
| 4,788,045 |
|
2012 | 1,079,092 |
| 1,086,543 |
| 1,097,541 |
| 1,109,695 |
| 4,372,871 |
|
2011 | 887,757 |
| 943,418 |
| 1,052,809 |
| 1,075,015 |
| 3,958,999 |
|
2010 | 721,967 |
| 698,890 |
| 745,376 |
| 804,684 |
| 2,970,917 |
|
2009 | 462,103 |
| 469,736 |
| 555,296 |
| 615,212 |
| 2,102,347 |
|
2008 | 363,615 |
| 393,682 |
| 460,167 |
| 454,922 |
| 1,672,386 |
|
2007 | 224,820 |
| 219,579 |
| 299,995 |
| 322,300 |
| 1,066,695 |
|
2006 | — |
| — |
| 10,689 |
| 157,742 |
| 168,431 |
|
| | | | | |
Xolair | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 425,243 |
| 428,171 |
| 491,372 |
| — |
| 1,344,786 |
|
2013 | 341,309 |
| 365,778 |
| 391,900 |
| 401,333 |
| 1,500,321 |
|
2012 | 310,234 |
| 314,638 |
| 347,796 |
| 340,431 |
| 1,313,100 |
|
2011 | 267,754 |
| 277,642 |
| 310,874 |
| 314,911 |
| 1,171,182 |
|
2010 | 228,859 |
| 225,878 |
| 251,055 |
| 263,389 |
| 969,179 |
|
2009 | 184,669 |
| 181,086 |
| 211,006 |
| 219,693 |
| 796,454 |
|
2008 | 137,875 |
| 169,521 |
| 177,179 |
| 183,753 |
| 668,329 |
|
2007 | 129,172 |
| 130,700 |
| 144,250 |
| 147,754 |
| 551,876 |
|
2006 | 95,241 |
| 99,354 |
| 112,608 |
| 118,002 |
| 425,204 |
|
| | | | | |
Perjeta | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 158,809 |
| 206,333 |
| 242,700 |
| — |
| 607,842 |
|
2013 | 34,008 |
| 55,076 |
| 66,353 |
| 87,949 |
| 243,386 |
|
2012 | — |
| — |
| 5,080 |
| 25,000 |
| 30,079 |
|
PDL BioPharma, Inc.
Q3 2014
November 10, 2014
|
| | | | | | | | | | |
Queen et al. Reported Net Sales Revenue by Product ($ in 000's) * |
Kadcyla | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 91,031 |
| 117,212 |
| 143,414 |
| — |
| 351,657 |
|
2013 | — |
| 21,459 |
| 73,626 |
| 85,906 |
| 180,991 |
|
| | | | | |
Tysabri | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 428,561 |
| 442,492 |
| 534,946 |
| — |
| 1,405,999 |
|
2013 | 434,677 |
| 451,358 |
| 387,407 |
| 403,334 |
| 1,676,776 |
|
2012 | 374,430 |
| 401,743 |
| 391,623 |
| 408,711 |
| 1,576,508 |
|
2011 | 329,696 |
| 356,876 |
| 388,758 |
| 381,618 |
| 1,456,948 |
|
2010 | 293,047 |
| 287,925 |
| 293,664 |
| 316,657 |
| 1,191,292 |
|
2009 | 221,854 |
| 229,993 |
| 257,240 |
| 285,481 |
| 994,569 |
|
2008 | 129,430 |
| 163,076 |
| 200,783 |
| 233,070 |
| 726,359 |
|
2007 | 30,468 |
| 48,715 |
| 71,972 |
| 94,521 |
| 245,675 |
|
2006 | — |
| — |
| — |
| 7,890 |
| 7,890 |
|
| | | | | |
Actemra | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 114,865 |
| 124,736 |
| 147,285 |
| — |
| 386,886 |
|
2013 | 87,703 |
| 91,374 |
| 97,961 |
| 124,815 |
| 401,852 |
|
2012 | 56,662 |
| 66,624 |
| 71,505 |
| 82,053 |
| 276,843 |
|
2011 | 30,433 |
| 35,370 |
| 46,709 |
| 48,671 |
| 161,183 |
|
2010 | 52,908 |
| 5,405 |
| 10,493 |
| 22,919 |
| 91,725 |
|
2009 | 19,504 |
| 17,920 |
| 30,313 |
| 39,888 |
| 107,625 |
|
2008 | 1,452 |
| 1,377 |
| 5,981 |
| 12,305 |
| 21,115 |
|
2007 | — |
| — |
| — |
| 1,137 |
| 1,137 |
|
| | | | | |
Gazyva | Q1 | Q2 | Q3 | Q4 | Total |
2014 | 3,095 |
| 8,697 |
| 11,531 |
| — |
| 23,323 |
|
| | | | | |
Entyvio | Q1 | Q2 | Q3 | Q4 | Total |
2014 | — |
| — |
| 5,347 |
| — |
| 5,347 |
|
| | | | | |
* As reported to PDL by its licensee | |
Totals may not sum due to rounding | | |